NCT04996654

Feasibility of a Novel Exergame-Based Training Concept for Older Adults With Mild Neurocognitive Disorder

Completed NA Last updated 12 October 2023

What this trial tests

NA trial testing Exergame in Mild Neurocognitive Disorder in 18 participants. Completed in 21 June 2022.

Timeline

12 July 2021

Primary endpoint
21 June 2022

21 June 2022

Quick facts

Lead sponsor	Eling DeBruin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	18
Start date	12 July 2021
Primary completion	21 June 2022
Estimated completion	21 June 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Exergame
• Usual Care

Conditions studied

• Mild Neurocognitive Disorder — all drugs for Mild Neurocognitive Disorder →

Sponsor

Eling DeBruin

Who can join

50 and older, any sex, with Mild Neurocognitive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this pilot study is to evaluate the feasibility (i.e. recruitment, adherence, compliance, attrition), usability (i.e. system usability), and acceptance (i.e. enjoyment, training motivation and perceived usefulness) of a newly developed exergame-based intervention concept for older adults with mNCD. As a secondary objective, preliminary effects of the intervention on cognition, brain resting-state functional connectivity, gait, cardiac autonomic regulation, and psychosocial factors (i.e. quality of life, and levels of depression, anxiety, and stress) will be explored. This allows to synthesize data for a sample size calculation on basis of a formal power calculation for a future RCT.

A two-arm, parallel-group, single-blinded (i.e. outcome evaluator of pre- and post-measurements blinded to group allocation) pilot randomized controlled study with an allocation ration of 2 : 1 (i.e. intervention : control) including 17 - 25 older adults with mNCD will be conducted between June and December 2021. The active control group will proceed with usual care as provided by the memory clinics where the patients are recruited. The intervention group will perform a twelve-week training intervention according to a newly developed exergame-based intervention concept in addition to usual care. Primary outcomes will be assessed throughout the training intervention period. The measurements of all secondary outcomes will be conducted at ETH Hönggerberg within two weeks prior to starting (PRE) and after completing (POST) the study intervention.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Making the Best Out of IT: Design and Development of Exergames for Older Adults With Mild Neurocognitive Disorder - A Methodological Paper.
   Manser P, de Bruin ED. · · 2021 · cited 24× · PMID 34955806 · DOI 10.3389/fnagi.2021.734012
2. Feasibility, usability, and acceptance of "Brain-IT"-A newly developed exergame-based training concept for the secondary prevention of mild neurocognitive disorder: a pilot randomized controlled trial.
   Manser P, Poikonen H, de Bruin ED. · · 2023 · cited 16× · PMID 37810620 · DOI 10.3389/fnagi.2023.1163388
3. Effectiveness of an Individualized Exergame-Based Motor-Cognitive Training Concept Targeted to Improve Cognitive Functioning in Older Adults With Mild Neurocognitive Disorder: Study Protocol for a Randomized Controlled Trial.
   Manser P, Michels L, Schmidt A, Barinka F, et al · · 2023 · cited 10× · PMID 36745483 · DOI 10.2196/41173
4. Domain-Specific Evaluation of Exergame Metrics Among Older Adults With Mild Neurocognitive Disorder: Secondary Analysis of 2 Randomized Controlled Trials.
   Kaiser W, de Bruin ED, Manser P. · · 2025 · cited 2× · PMID 40397948 · DOI 10.2196/65878